Table 2.
Evidence available at time of pre-reimbursement assessment in Austria and at time of FDA approval, levels of evidence
| Intervention | Product | Highest level of evidence at time of pre-reimbursement assessment (Austria) | LoE | Highest level of evidence: FDA application/approval (USA) | LoE |
|---|---|---|---|---|---|
| 1. Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction in patients with congenital heart defects | Melody™ | NB 2006 | FDA 2010 | 4 | |
| 2008 [14]: 4 retrospective + prospective case series, 8–68 pts | 5 | HDE approval based on 1 prospective case series 99 pts, requirement of 2 post-approval studies with 5y FU [13] | |||
| 2. Percutaneous aortic valve replacement/ TAVI | CoreValve® | 2007 | FDA 2014 | 2 | |
| SAPIEN XT™ | 2008 [16]: retrospective + prospective 10 case series, 8–86 pts | 5 | CoreValve® PMA approval based on 1 RCT, 656 pts [15] (CoreValve U.S. Pivotal Trial), requirement for post-approval study on extreme risk patients. | ||
| 2009 [18]: see 2008 + 4 case series, 12–646 pts 2010 [19]: see 2008 + 2009 + 6 cohort studies (registries), 4 HTAs | 4 | ||||
| 4 | SAPIEN XT™ PMA approval based on 1 RCT, 560 pts [17] (PARTNER II), requirement for post-approval study on inoperable patients cohort | 2 | |||
| 2 | |||||
| 2011 [20]: see 2008 + 2009 + 2010 + 1 RCT, 358 pts (PARTNER I) | |||||
| 3. Cardiac contractility modulation (CCM) for heart failure | Optimizer™ III/IV | NB 2007 | - | - | |
| 2008 [21]: 2 RCTs, 49/164 pts (FIX-HF-4/ OPTIMIZER) +2 case series 13/25 pts) | 2 | IDE Status: Optimizer™ III Optimizer™ III/IV Trial FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER®) ongoing | |||
| 2009 [22]: see 2008 + 1 RCT-Protokoll, 428 pts (FIX-HF-5/ OPTIMIZER) | 2 | ||||
| 2010 [23]: see 2009 | 2 | ||||
| 4. Percutaneous transluminal angioplasty (PTA) of periphery arteries with drug-eluting balloon (DEB) | In.Pact™ Amphirion + Admiral | NB 2009/11/12/13 | FDA 2014 | 1 + 3 | |
| 2013 [25]: 4 RCTs, 50–102 pts(2 × In.Pact™ DEBELLUM, PACIFIER, 2 × Cotovance™ THUNDER, FemPac) +2 cohort studies (registries: In.Pact™ Admiral, In.Pact™ Amphirion) | 1-2 | Lutonix DCB® PMA based on LEVANT 2 RCT, 476 pts + LEVANT 2 registry, 657 pts. [24] | |||
| Lutonix DCB® | |||||
| Cotavance™ | |||||
| Advance 18 PTX® | IDE Status: In.Pact™ Admiral based on SFA I and SFA II RCT, 331 pts | ||||
| LEGflow™ | No IDE Status: Cotavance™ (IDE suspended), Advance 18 PTX (only EU), LEGflow™ (RAPID trial EU),Freeway™ (only EU) | ||||
| ELUTAX SV™ | |||||
| Freeway™ | |||||
| 5. Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting balloon (DEB) | Dior® PCBr | NB 2007/09/11 | - | - | |
| SeQuent® DCB In.Pact™ Admiral | 2009 [26]: 2 RCTs, 52/108 pts (2x Cotavance™ PACCOCATH I, II) | 1-2 | IDE Status: In.Pact™ Admiral/ Medtronic based on SFA I and SFA II RCT, 331 pts | ||
| Cotavance™ | 2013 [27]: 5 RCTs for ISR, 50–271 pts (4 × SeQuent® PEPCAD II-IV + 1 × Cotavance™ PACCOCATH II FU) +1 RCT for SVD, 60 pts (Dior® PICCOLETO) +1 RCT for de-novo lesions, 84 pts (SeQuent®) | 1-2 | No IDE Status :Dior® PCB (only EU), SeQuent® DCB: (only EU), Cotavance™ (IDE suspended) | ||
| 6. Percutaneous repair of mitral regurgitation with the MitraClip | MitraClip®/Abbott | NB 2008 | 4 | FDA 2013 | |
| 2010 [28]: prospective case series (EVEREST I/II), 107 pts 2012 [30]: 2010 + 10 case series +1 RCT, 279 pts (EVEREST II) | 2 | MitraClip® PMA approval based on EVEREST II RCT, 279 pts., EVEREST II high-risk registry (EVEREST II HRR), 78 pts and EVEREST II Cont. access registry (REALISM HR), 853 pts [29], requirement of 2 post-approval studies (registries) | 2 + 3 | ||
| 7. Renal denervation | Symplicity™ RDN/Medtronic | NB 2008 | - | - | |
| 2011 [31]: 1 prospective case series (SYMPLICITY HTN-1), 50 pts; 1 RCT, 106 pts. (SYMPLICITY HTN-2) | 4, 2 | IDE Status: IDE approval study SYMPLICITY HTN-3, 535 pts. failed; 2014 approval process suspended [32], IDE approval study SYMPLICITY HTN-4 ongoing | |||
| 4, 2 | |||||
| 2012 [33]: 2011+ 1 case series, 153 pts. (FU SYMPLICITY HTN-1) | |||||
| 8. Endovascular repair of aortic aneurysms | Zenith® Fenestrated AAA Endovascular Graft | NB 2005/13 | FDA 2012 | 4 | |
| 2013 [34]: 2 HTAs +4 SR based on 1 (non-randomised) controlled study, 187 pts +7-20 case series, 196–368 pts | 3 | Zenith® Fenestrated AAA Endovascular Graft PMA approval based on 1 (historic case-) controlled study, 42 pts [35], requirement of a long-term follow-up study. | |||
| Ventana™ Fenestrated System | |||||
| IDE Status: Ventana™ Fenestrated System | |||||
| 9. Percutaneous transluminal angioplasty (PTA) with drug-eluting stents in peripheral arterial disease, upper limb and thorax | Femoropopliteal: | NB 2009/ 12/13 | 1 + 2 1 + 2 |
FDA 2012 Zilver® PTX® PMA approval based on Zilver PTX randomised study, 479 pts. [37] | 2 |
| Zilver® PTX® Innova™ | 2014 [36]: Femoropopliteal | ||||
| S.M.A.R.T.® | 3 RCTs, 36–479 pts (1 × Zilver® PTX study, 2 × S.M.A.R.T.® SCIROCCO I + II) +1 non-randomised CTs, 93 pts (Zilver®) +1 case series, 787 pts. | IDE Status: S.M.A.R.T.® Vascular Stent System No IDE Status: Innova™ Peripheral Vascular DES System (MAJESTIC in Australia, New Zealand, EU); XIENCE® Prime BTK; | |||
| Infrapopliteal: | |||||
| XIENCE® Prime BTK | Infrapopliteal | Yukon®; PROMUS Element™PlusDES BTK; CYPHER® Select (discontinued to be marketed) | |||
| Yukon® | 4 RCTs, 50–200 pts (1 × XIENCE® DESTINY, 1 × Yukon® YUKON-BTK, 2× CYPHER® ACHILLES) +3 non-randomised CTs, 58–103 pts +3 case series, 114–146 pts (all CYPHER® Select) | ||||
| PROMUS Element™PlusDES BTK | |||||
| CYPHER® Select | |||||
| 10. Percutaneous left atrial appendage closure for the prevention of thromboembolic events in patients with atrial fibrillation | Watchman® LAA Closure Technology | NB 2005/08/12/13 | 4 + 5 | - | - |
| 2011 [38]: 4 case series, 64–180 pts; 1 cohort study/ registry, 73 pts; 1 RCT, 542 pts (Watchman® PROTECT AF) | 2009: Watchman® LAA Closure Technology PMA approval based on RCT, 707 pts (PROTECT AF) declined [39] | ||||
| AMPLATZER™ Cardiac Plug | |||||
| 3 + 2 | |||||
| Coherex WaveCrest™ LAA Occlusion System | 2014 [40]: 2011 + 3 FU studies of PROTECT AF + | IDE Status: Watchman® LAA Closure, re-application with RCT PREVAIL, 407 pts; AMPLATZER™ Cardiac Plug (RESPECT), 980 pts | |||
| 3 case series, 52–86 pts +1 cohort study/ registry, n/a; 2 prospective CTs, 80/150 pts |
Legend: pts.: patients; NB: notified bodies; RCT: randomised controlled trial; FDA: Food and Drug Administration; IDE: investigational device exemption; PMA: premarket approval; HDE: humanitarian device exemption.